Adalvo Limited

Adalvo are honored to have been recognized by CPhI Pharma, where our CEO, Anil Okay, has been nominated as a finalist for the CEO of the Year Award!

We are pleased to announce our successful DCP submission for Desogestrel+Ethinylestradiol (0.15mg+0.02mg) film-coated tablets.

This accomplishment enables Adalvo to provide multiple treatment options to both partners and patients.

Our Desogestrel+Ethinylestradiol 0.15mg/0.02mg film-coated tablets were developed in collaboration with one of our strategic partners, based on the reference brand Mercilon film-coated tablets. The product is a low-dose contraceptive used by women to prevent pregnancy.

According to IQVIA, Desogestrel+Ethinylestradiol (0.15mg+0.02mg) generated approximately $85mn in global sales in 2022.

Building on this accomplishment, Adalvo continues to expand their Women's Health portfolio. As a distinguished player in this domain, we are delighted to offer a wide range of products, as outlined below:

Cyproterone + Ethinylestradiol, 2 mg + 0.035 mgDesogestrel, 75 mcgDesogestrel +...

Who says pharma events have to be all work and no play? Join us for an enjoyable break during CPHI 2023 on Wednesday, October 25th, starting at 16:00.

Adalvo is pleased to announce that the successful Pivotal BE Study for Afatinib Film-Coated Tablets has been completed and we are now preparing our dossier submission which is scheduled for November 2023.

Our product is Afatinib 20mg, 30mg, 40mg & 50mg FCT and has been developed based on the reference brand Giotrif® (Boehringer Ingelheim). This product is fully developed by our sister company, forming part of the Aztiq group.Afatinib is used in the treatment of non-small cell lung cancer and has been selling for $306 Mn across the globe in 2022, according to IQVIA.


Based on our positive results, we believe we will be in a first-to-file first-to-market position in all our major markets.

Adalvo Ltd. (Adalvo) and Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) (“Cosmo”) today announced a collaboration agreement for Rifamycin SV with MMX® technology in Europe, Asia-Pacific (APAC), Middle East/North Africa (MENA) and Latin America (LATAM) regions.

We are pleased to announce our successful DCP submission for Mirabegron prolonged release tablets. 

This product has been developed in collaboration with one of our strategic partners, based on the reference brand, Betmiga prolonged release tablets.  It is indicated in the treatment of urgency, increased micturition frequency and urgency incontinence.

The brand sold approximately $3130 Mn globally in 2022, with a Global 3Y CAGR of 5%, according to IQVIA.

Based on these regulatory submissions, Adalvo expects to obtain marketing authorisations that will be made available for our partners.

Adalvo is one of the few Companies able to complete this very difficult development of a complex product in the generic pharma space, which further showcases our ability to bring differentiated products to our partners, strengthening Adalvo's presence in the Urology segment.

Adalvo proudly acknowledges September as Pain Awareness Month, joining the global community in raising awareness about the challenges faced by individuals dealing with chronic pain.

In our pursuit of being at the forefront of innovation, we are delighted to share the news of our second successful DCP closure for Desmopressin. While the demand has been extraordinary, we are excited to offer a select few MAs to potential partners who wish to embark on this remarkable journey with us.

Our niche peptide product has been developed based on the reference brand Minirin Melt from Ferring which is indicated for the treatment of diabetes insipidus, primary nocturnal enuresis and nocturia. The brand sold $116Mn globally in 2022, according to IQVIA.

Adalvo is one of the very few companies working on this complex niche peptide product which underpins Adalvo's robust R&D strengths and capabilities, and demonstrates our ability to continuously offer highly differentiated, value-added niche products to our partners.

Adalvo is pleased to announce a new collaboration with Eurofarma, a Brazilian-owned multinational pharmaceutical company that promotes access to health and quality of life with treatments at a fair price and profitable operations.

Adalvo is proud to announce the launch of our Q3 2023 Product Dossier. Offering an exclusive glimpse into the advancing strides we have made over the last quarter, reflecting Adalvo's unwavering dedication in bringing high quality generic pharmaceuticals and biosimilar medicines to market with our esteemed commercial partners around the world.

Adalvo is excited to announce the launch of Pomalidomide Hard Capsules 1/2/3/4mg in Canada.

Adalvo is thrilled to announce the expansion of its partnership with Teva, signing a licensing deal for a blockbuster small molecule in the oncology segment aimed at addressing rare diseases with limited treatment options.

Adalvo is proud to share a significant achievement in our pursuit to making a difference for patients around the world. Last week, the company successfully filed three distinct INN DCP applications for Azelastine+Fluticasone Nasal Spray, Adapalene/ Benzoyl peroxide, and Dapagliflozin, all within one day.

We are pleased to announce our successful DCP submission for Dapagliflozin 10mg film-coated tablets. This product has been developed in collaboration with one of our strategic partners.

Our product has been developed based on the reference brand Forxiga 10mg film-coated tablets, which is indicated in children, aged 10 years and above, for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, and in adults for the treatment of symptomatic chronic heart failure and chronic kidney disease.

The brand sold approximately $8bn globally in 2022, having a significant growth potential with Global 3Y CAGR at +35%, according to IQVIA. 

Adalvo is pleased to announce our successful DCP submission for Adapalene + Benzoyl Peroxide Gel.

Adalvo are pleased to announce our successful DCP submission for Azelastine Hydrochloride/ Fluticasone Propionate 137 microgram/50 microgram Nasal Spray.

Adalvo is thrilled to have successfully executed Dimethyl Fumarate 120/240mg Capsules in Mexico, with our esteemed partners, Corne.

Adalvo is delighted to highlight the expansion of its portfolio with the well-established Dimetindene Gel 0.1% (1mg/g). 

Adalvo is delighted to announce the successful DCP submission of our Dydrogesterone 10mg tablets. Adalvo takes great pride in being amongst the first wave of filers in the EU, with this dossier.